Alfapump® System in the Treatment of Refractory or Recurrent Ascites (POSEIDON Study)
Active, not recruiting · Not applicable · NCT03973866
Conditions: Ascites
At a glance
- Research payments reported, 2025
- $100,536
- U.S. investigators named
- 3
- Sites paid
- 3
- Planned or actual enrollment
- 110
About the trial
- Sponsor
- Sequana Medical N.V.
- Tested
- Alfapump (device)
- Dates
- Started 2019-09-16; completion 2024-06-30
- Results posted
- Not yet
The POSEIDON study is a multi-center, prospective, single arm, crossover pivotal study enrolling up to 70 pivotal cohort patients and up to 45 additional Roll-in patients with refractory or recurrent ascites at up to 20 sites. Pivotal cohort patients will undergo a 3-month pre-implant observation phase after enrollment, followed by implantation of the alfapump and 24 months of post-implant follow up. An analysis will be conducted to support an application for device approval when a minimum of 40 treated pivotal cohort patients are through 6 months.
From ClinicalTrials.gov, last updated 2022-12-01. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sequana Medical US Inc. reported $100,536 in research payments for this study in 2025 (4 payments).
Products named: Alfapump System
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Hugo E. Vargas, M.D. Gastroenterology · Scottsdale, AZ
- Kuchikula R. Reddy, MD Gastroenterology · Philadelphia, PA
- Jasmohan S. Bajaj, MD Gastroenterology · Richmond, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Richmond Institute for Veterans Research $53,074
- Hospital of Univ of Pennsylvania, PA $45,262
- Mayo Clinic Hospital, AZ $2,200
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.